The compounding conundrum

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Sam Cohen of IHRB can’t seem to make up his mind. One minutes he says that he has all his bottles compounded by a pharmacist. When he is reminded that this would be a criminal offence, especially due to the fact that he is Prohibited by the Health Care Complaints Commission from supplying or selling any medications, he changes his story and says that he uses Activance to which he claims to add his own exclusive secret natural herbal extracts that he claims are the special ingredients (which he calls his intellectual property and his Indian Curries).

Any which way he cares to phrase it, it is illegal. Sam Cohen is Prohibited from supplying or selling any medications. If he is claiming that he is using Activance (as he had done), then you ought to know that Activance has been officially discredited as a useless product in terms of hair loss and/or hair regrowth (and you can read about it here). All the bold claims about Activance have been rejected by the Complaints Resolution Panel.

Then Sam Cohen says that if he were to sell Minoxidil, he cannot see what the big deal is, because anyone can walk into a pharmacy and purchase Minoxidil without a prescription. This is only true for 5% and lower. However, Sam Cohen’s price-list shows that he sells Minoxidil up to 15% which does need a prescription. However, whether it is 2% or 5% or 15%, Sam Cohen is Prohibited from supplying or selling. Furthermore, not only is Sam Cohen Prohibited, but also everyone else who is not a pharmacist is prohibited by law. You see, selling such products can only be done by a pharmacy or a person who is licensed. Neither Sam Cohen nor the Institute of Hair Regrowth and Beauty are licensed. The analogy of ‘anyone can walk into a chemist and purchase Minoxidil’ is a red herring. It’s like saying that any adult can walk into a bottle-shop and purchase cigarettes and whisky. That is true. However, that same customer cannot on-sell tobacco and alcohol! It would be a grave offence. So, being able to buy Minoxidil, does not authorise IHRB and Sam Cohen to on-sell Minoxidil (and certainly not after he supposedly injects his secret Indian Curries that he can never prove exist in terms of them being anything more than useless water or hair colouring, and he certainly cannot prove that they are efficacious in terms of hair growth (as is required by law that he proves their efficacy; and as is required by law that if they were to exist, they would need to be Registered with the TGA (Therapeutic Goods Administration) which they are not!

Anyway, the public and people within the industry have been misguided about what can be compounded and how it can be compounded. For this reason, I sent an email to the Ministry of Health. The Acting Manager who is also the Principal Pharmaceutical Officer, responded to my queries, as you can read below. My questions are in green. The responses are in red.

QUESTION A

Minoxidil up to 5% is an S2 poison. [S2 means that it can only be sold by a pharmacy and NOT by Sam Cohen or IHRB.]

Can any person walk into a “compounding” pharmacist and order this product without a prescription?

Indeed, anyone can walk in and purchase J&J’s Regaine 5% Minoxidil. So can they just walk in and order one to be compounded, without a prescription?

No an S2 product or an S3 product does not require a doctor’s prescription… the patient can request it to be made and the pharmacist must provided it labelled in the patient’s name and a record be made of its supply (But why would the pharmacist make it up extemporaneously compd it if it’s already available at a much cheaper cost to the patient?

[It was proved recently that Sam Cohen had many products in stock that had no patient name. When IHRB was raided by Police and HCCC, his then pharmacist was also raided by Health Officials. What they found was that the pharmacist was supplying products in bulk, at wholesale, without any labels and to no specific patient. For these and other breaches, the pharmacist was de-registered, and he his career was shattered. You can read about that drama if you click here.]

QUESTION B

I understand that compounding must be made for a specific individual. So does that mean that any 5% Minoxidil that is Compounded, must have a label on it, showing the client name? Why must it show a name, if the exact product (J&J’s Regaine) can be purchased without a client’s name on it?

It is called pharmacist prescribing and it must be made up and labelled in the patient’s name and supplied directly to the patient. If it’s made up regardless if whether you can buy a similar product already made up off the shelf it must be labelled and a record of the supply kept in their records (usually on the computer)

Note that the Ministry of Health official is saying that the product must be supplied ‘directly to the patient’. This means that Sam Cohen cannot be the middle man. He cannot sell it or have anything to do with it. He cannot inject his herbs and spices in it. He cannot supply it. He cannot order it. He cannot do anything. The pharmacist must own the relationship with the client, directly, without any middle man who wants to sell it illegally and make a profit and charge $4900 as a sign-on fee for absolutely nothing at all, while locking clients into a dubious contract. When you go and purchase headache tablets from a store, you do not pay $4900 and sign a contract!

QUESTION C

A customer can walk into any chemist and purchase Regaine. There are no limits to the quantity that can be purchased.

Wrong a pharmacist can only supply(S2, S3, S4 and S8’s in a quantity and for a purpose that accords with therapeutic standards

So presumably, one can order 100 bottles

Wrong would not be appropriate.

Assuming the pharmacist exercises a duty of care, and explains the risks, and warns the customer to only use as directed, then is there any limitation on quantity?

YES… supply according to standard

I imagine there is not a limit to Regaine.

WRONG 100 bottles could not be humanly used for one person before its expiry when used as labelled.

However, is there a duty by the pharmacist to worry about on-selling?

YES that is why can only supply in qty and for purpose that accords with therapeutic standards

Or is that side of things not the real concern of the pharmacist?

answered above

Is the question of quantity an issue for an S2?

Definitely

What’s stopping Mr Cohen from purchasing Regaine in bulk?

ANSWERED

One scenario might be that he could open the 100 bottles and re-bottle them in his own blank bottles and on-sell them at a profit (notwithstanding that he is unlicensed and prohibited)

This would be considered manufacturing to re-label and would be an offense

QUESTION D

If there are no limits to supplying an S2 like Regaine, then would there be any limits to supplying a COMPOUNDED S2 bottle of 5% Minoxidil?

Again supply in qty and for a purpose only

If no prescription is required for the compounding of S2, then are there limits for compounding S2 for an individual?

Answered

In other words, what is stopping someone like Mr Sam Cohen finding a compounding pharmacist and just ordering in bulk?

Answered